FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General & Plastic Surgery ×
18,288 results
2953–2976 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Nov 29, 2018
Thoraguard System
K181667 · BTA
Centese, Inc.
General & Plastic Surgery · 157d
Cleared Nov 28, 2018
AEON Endoscopic Stapler
K182380 · GDW
Lexington Medical, Inc.
General & Plastic Surgery · 89d
Cleared Nov 27, 2018
Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator...
K182801 · GEI
Integra LifeSciences Corporation
General & Plastic Surgery · 56d
Cleared Nov 26, 2018
HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE...
K183009 · GEI
Hemostatix Medical Technologies, LLC
General & Plastic Surgery · 26d
Cleared Nov 23, 2018
MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)
K180643 · FRO
Medcu Technologies , Ltd.
General & Plastic Surgery · 256d
Cleared Nov 21, 2018
PINPOINT Endoscopic Fluorescence Imaging System
K182606 · GCJ
Novadaq Technologies Ulc. (Now A Part...
General & Plastic Surgery · 61d
Cleared Nov 19, 2018
Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke...
K182772 · GEI
Covidien
General & Plastic Surgery · 49d
Cleared Nov 16, 2018
Hair Boom 69
K182562 · OAP
Wontech
General & Plastic Surgery · 59d
Cleared Nov 15, 2018
CanGaroo Neuro Envelope (small)
K182255 · FTM
Aziyo Biologics, Inc.
General & Plastic Surgery · 87d
Cleared Nov 15, 2018
Amsel Endo Occluder
K180650 · FZP
Amsel Medical Corporation
General & Plastic Surgery · 247d
Cleared Nov 14, 2018
CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control
K182882 · HRX
Conmed Corporation
General & Plastic Surgery · 30d
Cleared Nov 14, 2018
Voyant Maryland Fusion Device
K182653 · GEI
Applied Medical Resources Corp.
General & Plastic Surgery · 50d
Cleared Nov 14, 2018
New Era
K182604 · GEX
Step UP Skin Laser, LLC
General & Plastic Surgery · 54d
Cleared Nov 14, 2018
Miracu
K172602 · NEW
Feeltech Co., Ltd.
General & Plastic Surgery · 441d
Cleared Nov 08, 2018
Geistlich Derma-Gide
K182838 · KGN
Geistlich Pharma AG
General & Plastic Surgery · 30d
Cleared Nov 08, 2018
neoClose PDS
K173917 · GCJ
Neosurgical, Ltd.
General & Plastic Surgery · 321d
Cleared Nov 05, 2018
1688 Camera Control Unit
K182160 · GCJ
Stryker
General & Plastic Surgery · 88d
Cleared Nov 05, 2018
ConnectedOR Hub with Device and Voice Control
K181258 · GCJ
Stryker
General & Plastic Surgery · 178d
Cleared Nov 02, 2018
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
K182616 · NQQ
Ninepoint Medical, Inc.
General & Plastic Surgery · 42d
Cleared Nov 02, 2018
Cellene CO2 Laser System
K182270 · GEX
Bio-Med USA, Inc.
General & Plastic Surgery · 72d
Cleared Nov 02, 2018
Invia White Foam NPWT
K180415 · OMP
Medela AG
General & Plastic Surgery · 260d
Not Cleared Nov 02, 2018
Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System
DEN170092 · QDG
Fluoptics
General & Plastic Surgery · 315d
Not Cleared Nov 02, 2018
Parathyroid Detection (Model PTeye) System
DEN170056 · QDF
Aibiomed, Corp.
General & Plastic Surgery · 403d
Cleared Oct 31, 2018
Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
K182588 · NUJ
Surgical Instrument Service and...
General & Plastic Surgery · 41d